ISSUE

: FDA has recently published several guidance documents/frameworks for use of RWE to support regulatory decision-making for drugs, biologics, and medical devices. If we are to realize the full promise of RWE, we must address the unmet needs in health care where the utilization of RWE in medical devices can positively impact on quality, access, and cost. Clarity is needed about what RWE means for medical devices and how it can be used most effectively to support regulatory or reimbursement decision-making, so that we can set appropriate expectations about what RWE can add to conversations between regulatory agencies, manufacturers, health care providers, and payers. While RWE is an increasingly used for drugs and biologics, there may be some unique challenges to generate RWE, specifically for medical devices and diagnostics, that may create barriers to broader utilization of RWE for medical devices. As a result, there is an urgent need to explore the opportunities and challenges of wide use of RWE from the perspectives of all relevant stakeholders.

OVERVIEW

: This panel will debate unmet needs, opportunities, challenges, and benefits of wide use of RWE as relates to the development, commercialization, and market access of medical devices for health care delivery and health care reimbursement from different perspectives: a regulatory agency, industry, and payer. Lizheng Shi will moderate the panel and provide an overview of the current landscape of RWE with a focus on medical devices, as well as pose key questions for the panelists to debate: What are best practices for ensuring appropriate use of RWE of medical devices to improve product development, validation, and demonstration of benefits to patient care. What RWE requirements are different between medical devices (including diagnostic tests) and drugs/biologics? What type of tools are needed to promote the broader use of RWE in the evaluation of medical devices?